Smarter Thinking. Simpler Design.
Surgical Manual
Genesis
2
3
TABLE OF CONTENTS
GENESIS IMPLANT SURGICAL MANUAL
SURGERY
Genesis Characteristics
4
Surgical Considerations
5
Genesis Surgical Sequence
9
Depth Markings
11
Drilling Sequence
12
Product specifications are subject to change without notice.
Items illustrated are not to scale.
4
Design Features
The Genesis dental implant features a TiLobe
®
connection. This internal
6-lobe connection combines the benefits of a tapered, internal lobed design
and integrated pilot (self-aligning feature), providing a secure implant/
abutment connection. The same Abutment Screw can be used for all
implant diameters.
Dimensions
• The Ø3.5 mm and Ø3.8 mm Genesis implants share the same
prosthetic connection.
• The Ø5.5 mm and Ø6.5 mm Genesis implants share the same
prosthetic connection.
The Ø3.5 mm tapered Genesis is available in 10, 11.5,
13 and 16 mm lengths and can be restored with 4.0
and 5.0 prosthetic components.
The Ø3.8 mm tapered Genesis is available in 8.5, 10,
11.5, 13 and 16 mm lengths and can be restored with
4.0 and 5.0 prosthetic components.
The Ø4.5 mm tapered Genesis is available in 8.5, 10,
11.5, 13 and 16 mm lengths and can be restored with
5.0 and 6.0 prosthetic components.
The Ø5.5 mm tapered Genesis is available in 8.5, 10,
11.5, and 13 mm lengths and can be restored with 5.0
and 6.0 prosthetic components.
The Ø6.5 mm tapered Genesis is available in 8.5, 10,
11.5, and 13 mm lengths and can be restored with 6.0
prosthetic components.
8.5˚ Taper
6-Lobe Connection
Pilot
3.5
3.8
3.5
3.8
3.5
3.8
3.5
3.8
3.5
3.8
GENESIS
CHARACTERISTICS
5
Considerations
INDICATIONS
The Genesis Implant System is intended for use in single-stage or two-
stage surgical procedures in all types of bone in partially or fully edentulous
mandibles and maxillae. The Genesis Implant System supports single or
multiple-unit restorations to re-establish patient chewing function and
esthetics. Genesis implants are intended for placement following natural
tooth loss or for immediate placement into an extraction socket. Immediate
function may be achieved when good primary stability is established and
appropriate occlusal loading is applied.
CONTRAINDICATIONS
• Patients with uncontrolled or severe cases of hyperthyroidism,
diabetes, malignancies, renal disease, liver problems,
hypertension, leukemia, severe vascular heart disease, hepatitis,
immunosuppressive disorders, collagen and bone diseases, or
other serious illnesses
• Patients with titanium allergies
• Patients with alveolar ridge dimensions that are not sufficient to
accommodate and sustain proper implant placement
• Patients with systemic, local oral, or respiratory infection
For additional information, please consult the
Genesis Implant Instructions for Use
.
SOFT TISSUE HEALING AND TEMPORIZATION
Following the placement of a Genesis implant, soft tissue can be contoured
using a titanium Healing Abutment or a custom fabricated temporary
abutment.
A Temporary Abutment can be placed at this time for immediate
temporization. The acrylic portion of the Temporary Abutment bonds with
dental composite/acrylic allowing for custom esthetic contouring directly
to the Temporary Abutment.
SURGICAL
CONSIDERATIONS
PATIENT EVALUATION AND SELECTION
Successful implant treatment requires the coordinated efforts of the
implanting surgeon, the restorative dentist, and the dental laboratory
technician. Proper patient selection is important for long-term function of a
dental implant. The following factors should be considered prior to implant
surgery:
• General medical history
• Oral hygiene
• Patient’s expectations
• General dentistry and product indications and contraindications
• Anatomical landmarks related to implant positioning
• Inter-occlusal clearance (the space available between alveolar
crest and opposing dentition)
• Ridge width in relation to the implant diameter
• Emergence profile of the restoration in relation to prosthetic
platform diameters
BONE QUALITY
While one method of classifying bone density is shown in the images below,
different combinations of cortical and trabecular bone in varying thicknesses
and densities can occur. These typically differ by jaw location. The clinician is
responsible for assessing bone density of the surgical site and choosing the
appropriate protocol.
D1 Bone
Cortical bone
D2 Bone
Cortical bone/trabecular
D3 Bone
Cortical bone/trabecular
D4 Bone
Cortical bone/trabecular
6
Surgical Guide
Available planning software provides both clinicians and
technicians the ability to plan implant placement three-
dimensionally in conjunction with CT scans. A surgical guide
could aid in the site preparation and placement of implants.
Tapping Procedure
Tapping is essential when placing a Genesis implant in dense
bone. Without tapping, the insertion torque will increase
making it difficult to seat the implant. Refer to the drill and
tap sequences on pages 11-13 for tapping recommendations.
SURGICAL
CONSIDERATIONS
Implant Selection
Implant selection should be made with the final restorative
result as the primary consideration.
Selecting implants in this manner aids in maximizing
biomechanical stability and proper contouring of the soft
tissue. Choosing an implant with a slightly smaller platform
than the emergence of the tooth being replaced will provide
support of the soft tissue and optimize the esthetic result.
Implant placement and healing abutment selections should
be based on the following:
• Emergence profile of the restoration in relation to
the prosthetic platform diameter
• Height and diameter of the crown as it emerges
through the tissue
Implant selection can also be completed with the use of sizing
overlays. Transparent implant sizing overlays (100% and
125% magnification) are available.
Surgical Taps Laser Marking
7
Surgical Kit
The Surgical Kit must be cleaned and sterilized prior to use. For further
information, please consult Keystone Dental’s
Instructions for Use
.
• All surgical instruments are provided non-sterile.
• All drills are non-irrigated and require external irrigation when
preparing the osteotomy.
• All drills must be inspected for signs of wear, damage or
discoloration.
The drill markings and color-coding facilitate proper instrument selection.
It is recommended to inspect the latch-lock shank after each use. Surgical
instruments are susceptible to damage and wear and should be inspected
before use. The number of uses per drill will vary and depends on a
variety of factors including bone density, proper handling and cleaning.
It is recommended to replace drills after 20 osteotomies, as repeated
sterilizations and use may affect cutting efficiency and color appearance.
Drilling and Tapping Procedures
The Final Drills are designed to collect bone. During surgery, it is
recommended to remove the collected bone from the drill before proceeding
to the final depth marking. This will reduce the downward force applied to
the handpiece.
• In certain instances, tapping is required (see Surgical Sequence,
Step 8). Depending on bone density, a maximum tapping speed
of 20-50 rpm is recommended.
• It is recommended to avoid lateral pressure during drilling and
tapping procedures as the resulting osteotomy may be oversized
and/or redirected.
• When using the Final Drills, it is not recommended to use an in-
and-out technique as this may inadvertently enlarge the site.
SURGICAL
CONSIDERATIONS
8
PRE-CLEANING
• Used instruments should be soaked immediately in instrument
cleaning solution to avoid the drying of blood, saliva and tissue
residue.
• Used surgical trays including grommets must be cleaned with a
suitable disinfectant.
• Multiple-part instruments must be disassembled prior to
cleaning and sterilization.
• Internal debris/residue of instruments must be removed with a
soft brush.
• Instruments should be inspected, cleaned separately and
discarded if damaged.
PRINCIPLE CLEANING
• Best results are achieved if surgical instruments are cleaned by
material type.
• Instruments and trays can be cleaned and disinfected in a
dedicated dishwasher or alternatively by hand, followed by
an ultrasonic bath with a detergent appropriate for surgical
instruments.
• Instruments and trays must be rinsed and dried thoroughly.
STERILIZATION
Instruments and tray should be autoclaved with a sufficient drying cycle to
avoid instrument corrosion. Instruments should be placed in the tray and
wrapped in sterilization paper or sterilization packs featuring indicating
tape and date of sterilization.
• Steam Sterilization Gravity Cycle: 134˚C (~273°F)
20 minute exposure / 40 minute dry time
• Steam Sterilization Pre Vacuum Cycle: 134˚C (~273°F)
4 minute exposure / 40 minute dry time
SURGICAL MOTOR AND HANDPIECE
Cleaning and maintenance instructions for W&H handpieces and motors
can be found on www.wh.com.
Instrument Care
Instruments must be cleaned and sterilized prior to first and after each use
based on established procedures. Proper instrument care is an important
part of successful implant dentistry.
Implant Packaging
Each Genesis implant is gamma-sterilized, packaged in a vial, sealed in a
tray with a Tyvek
®
lid. The flip-open lid on the vial contains a cover screw.
The sealed tray contains a label identifying the implant type, diameter and
length, as well as other important device information. Inside, pre-printed
patient labels with product data and the lot number are provided. These are
adhesive labels that should be affixed to the patient’s chart.
Opening instructions:
1. The Tyvek lid on the tray is peeled back and placed into the sterile field.
2. The patient labels are affixed to the patient’s chart.
3. The implant lid is flipped open to gain access to the selected Genesis
implant.
The implant may now be removed from the vial, delivered to the site and
placed using one of the following options.
Implant Delivery
The implant is delivered to the osteotomy with an Implant Driver.
• The Implant Driver is aligned with the implant. While pressure is
applied, the Implant Driver is rotated at a speed less than 20 rpm
until the lobes of the Implant Driver engage the implant lobes. A
tactile and/or audible click may occur indicating the Implant Driver
is engaged. The implant is lifted out of the vial and placed into the
osteotomy.
• The Implant Driver is pulled straight up to disengage the Implant
Driver from the implant. Special care should be taken in very soft
bone to not disrupt primary stability.
Depending on the clinical situation and accessibility, two different Implant
Drivers are available. The Implant Driver/latch type can be used with a surgical
motor, a Surgical Ratchet or a Surgical Hand Driver. For limited inter-occlusal
clearance, a direct-to-ratchet Implant Driver is available.
Implant Placement
The final implant position is at the discretion of the surgeon. Each case should
be evaluated on the basis of placement, protocol and type of implant prior to
osteotomy preparation. It is recommended to place a Genesis implant at bone
level.
SURGICAL
CONSIDERATIONS
9
Step 5 (Optional)
Again, the osteotomy is widened with a
Ø3.8 mm Final Tapered Drill to the
required depth, at 600-800 rpm. A Ø3.8
mm Implant Depth Gauge can be
placed for verification of the osteotomy.
Step 6
Then the osteotomy is further widened
with the Ø4.5 mm Final Tapered Drill at
600-800 rpm.
Step 7
The osteotomy is cleared of bone debris
and the Ø4.5 mm Implant Depth Gauge
is inserted. It is recommended to verify
the proper osteotomy depth with a
radiograph.
Step 8
In bone quality D1 and D2, it is
recommended to use a Surgical Tap to
finalize the osteotomy. In this case, a
Ø4.5 mm Surgical Tap is inserted with
slight pressure at 20-50 rpm to the
appropriate depth. The Surgical Tap is
then removed by reversing the rotation.
Step 1
An incision of the appropriate design
is made and the flap elevated. The
Ø2.0 mm Initial Drill has markings
at lengths of 8.5, 10, 11.5, 13 and
16 mm and should be inserted to the
required depth, at 1200-1500 rpm.
Step 2
The proper position of the osteotomy
is verified with the Parallel Pin. It is
recommended to thread floss though
the opening of the Parallel Pin to
ensure retrieval if dislodged.
2.0 x 8.5-16 mm
2.0 mm
3.5 x 13
3.8 x 13
4.5 x 13
2.0 x 8.5-16 mm
2.0 mm
3.5 x 13
3.8 x 13
4.5 x 13
2.0 x 8.5-16 mm
2.0 mm
3.5 x 13
3.8 x 13
4.5 x 13
2.0 x 8.5-16 mm
2.0 mm
3.5 x 13
3.8 x 13
4.5 x 13
2.0 x 8.5-16 mm
2.0 mm
3.5 x 13
3.8 x 13
4.5 x 13
2.0 x 8.5-16 mm
2.0 mm
3.5 x 13
3.8 x 13
4.5 x 13
SURGICAL
SEQUENCE
Surgical Sequence - Genesis Ø4.5 mm x 13 mm
(For demonstration purposes)
Step 3
The osteotomy is further widened with
a Ø3.5 mm Final Tapered Drill to the
required depth, at 600-800 rpm.
GENESIS
SURGICAL SEQUENCE
13 mm
13 mm
13 mm
13 mm
13 mm
Step 4 (Optional)
At this point the osteotomy is cleared
of bone debris and optionally, the
Ø3.5 mm Implant Depth Gauge can be
inserted.
10
Step 9
Handpiece Insertion
With the Implant Driver connected to the
handpiece, the internal lobes are fully engaged
by the Implant Driver and carefully removed
from the vial. It is then carried to the osteotomy
and inserted at 15-20 rpm.
NOTE: Depending on bone quality and osteotomy preparation, the insertion torque may vary from 20-60 Ncm.
Step 10
Single-Stage Surgery
In a single-stage surgery the healing abutment
is placed with a Quad Driver to help contour
the soft tissue during the healing phase.
The flap margins are positioned around the
Healing Abutment and sutured in a tension-
free manner.
GENESIS
SURGICAL SEQUENCE
2.0 x 8.5-16 mm
2.0 mm
3.5 x 13
3.8 x 13
4.5 x 13
Ratchet Insertion
The Surgical Ratchet can be used in
addition or instead of a handpiece to
finalize the insertion of the implant by
engaging the Implant Driver into the
Ratchet.
2.0 x 8.5-16 mm
2.0 mm
3.5 x 13
3.8 x 13
4.5 x 13
2.0 x 8.5-16 mm
2.0 mm
3.5 x 13
3.8 x 13
4.5 x 13
2.0 x 8.5-16 mm
2.0 mm
3.5 x 13
3.8 x 13
4.5 x 13
Two-Stage Surgery
In a two-stage surgery the Cover Screw is
placed with a Quad Driver and the flap
margins are repositioned and sutured in a
tension-free manner.
11
DRILL
SEQUENCE
Depth Markings
Genesis Drilling Sequence Ø4.5 x 13 mm
Final Drills Over Drill Depth
Ø3.5mm Tapered Final Drills +1.29 mm
Ø3.8mm Tapered Final Drills +1.35 mm
Ø4.5mm Tapered Final Drills +1.45 mm
Ø5.5mm Tapered Final Drills +1.45 mm
Ø6.5mm Tapered Final Drills +1.95 mm
DEPTH MARKINGS
*The Genesis implant drills feature the following laser markings:
• Thin laser mark represents implant length
• Bottom of thick laser mark represents implant length + 1 mm sub-crestal
• Top of thick laser mark represents implant length + 2 mm sub-crestal
The actual drill tip is not included in the designated drill length and must be
considered when preparing the osteotomy.
+2mm
+1mm
2.0 x 8.5-16 mm
2.0 mm
3.5 x 13 mm
4.5 x 13 mm
4.5 x 13 mm
10 mm
8.5 mm
11.5 mm
13 mm
16 mm
+2 mm
+1 mm
+2mm
+1mm
2.0 x 8.5-16 mm
2.0 mm
3.5 x 13 mm
4.5 x 13 mm
4.5 x 13 mm
10 mm
8.5 mm
11.5 mm
13 mm
16 mm
+2 mm
+1 mm
Over Drill Depth
*+2 mm
*+1 mm
Bone level
Ø4.5 x 13 mm
Depth Markings
Genesis Drilling Sequence Ø4.5 x 13 mm
+2mm
+1mm
2.0 x 8.5-16 mm
2.0 mm
3.5 x 13 mm
4.5 x 13 mm
4.5 x 13 mm
10 mm
8.5 mm
11.5 mm
13 mm
16 mm
+2 mm
+1 mm
Ø2.0 mm
Initial Drill
16 mm
13 mm
11.5 mm
10 mm
8.5 mm
Ø2.0 mm
Parallel Pin
Ø3.5 x 13 mm
Final Drill
Ø4.5 x 13 mm
Final Drill
Ø4.5 x 11.5-13 mm
Implant Depth Gauge
Ø4.5 x 10-13 mm
Surgical Tap
Ø4.5 x 13 mm
Genesis Tapered Implant
Over Drill Depth
Bone Level
11.5 mm
12
Implant
Length
Ø3.5 Drilling Sequence
10 mm 2.0 Initial Drill Parallel Pin
3.5 x 10 mm
Final Drill
3.5 mm Depth
Gauge
3.5 mm
Tap
11.5 mm 2.0 Initial Drill Parallel Pin
3.5 x 11.5 mm
Final Drill
3.5 mm Depth
Gauge
3.5 mm
Tap
13 mm 2.0 Initial Drill Parallel Pin
3.5 x 13 mm
Final Drill
3.5 mm Depth
Gauge
3.5 mm
Tap
16 mm 2.0 Initial Drill Parallel Pin
3.5 x 16 mm
Final Drill
3.5 mm Depth
Gauge
3.5 mm
Tap
Implant
Length
Ø3.8 Drilling Sequence
8.5 mm 2.0 Initial Drill Parallel Pin
3.5 x 8.5 mm
Final Drill
3.8 x 8.5 mm
Final Drill
3.8 mm Depth
Gauge
10 mm 2.0 Initial Drill Parallel Pin
3.5 x 10 mm
Final Drill
3.8 x 10 mm
Final Drill
3.8 mm Depth
Gauge
11.5 mm 2.0 Initial Drill Parallel Pin
3.5 x 11.5 mm
Final Drill
3.8 x 11.5 mm
Final Drill
3.8 mm Depth
Gauge
3.8 mm
Tap
13 mm 2.0 Initial Drill Parallel Pin
3.5 x 13 mm
Final Drill
3.8 x 13 mm
Final Drill
3.8 mm Depth
Gauge
3.8 mm
Tap
16 mm 2.0 Initial Drill Parallel Pin
3.5 x 16 mm
Final Drill
3.8 x 16 mm
Final Drill
3.8 mm Depth
Gauge
3.8 mm
Tap
Implant
Length
Ø4.5 Drilling Sequence
8.5 mm 2.0 Initial Drill Parallel Pin
3.5 x 8.5 mm
Final Drill
4.5 x 8.5 mm
Final Drill
4.5 mm Depth
Gauge
10 mm 2.0 Initial Drill Parallel Pin
3.5 x 10 mm
Final Drill
4.5 x 10 mm
Final Drill
4.5 mm Depth
Gauge
4.5 mm
Tap
11.5 mm 2.0 Initial Drill Parallel Pin
3.5 x 11.5 mm
Final Drill
4.5 x 11.5 mm
Final Drill
4.5 mm Depth
Gauge
4.5 mm
Tap
13 mm 2.0 Initial Drill Parallel Pin
3.5 x 13 mm
Final Drill
4.5 x 13 mm
Final Drill
4.5 mm Depth
Gauge
4.5 mm
Tap
16 mm 2.0 Initial Drill Parallel Pin
3.5 x 16 mm
Final Drill
4.5 x 16 mm
Final Drill
4.5 mm Depth
Gauge
4.5 mm
Tap
DRILLING SEQUENCE
13
Implant
Length
Ø6.5 Drilling Sequence
8.5 mm 2.0 Initial Drill Parallel Pin
3.5 x 8.5 mm
Final Drill
4.5 x 8.5 mm
Final Drill
5.5 x 8.5 mm
Final Drill
6.5 x 8.5 mm
Final Drill
6.5 mm Depth
Gauge
6.5 mm
Tap
10 mm 2.0 Initial Drill Parallel Pin
3.5 x 10 mm
Final Drill
4.5 x 10 mm
Final Drill
5.5 x 10 mm
Final Drill
6.5 x 10 mm
Final Drill
6.5 mm Depth
Gauge
6.5 mm
Tap
11.5 mm 2.0 Initial Drill Parallel Pin
3.5 x 11.5 mm
Final Drill
4.5 x 11.5 mm
Final Drill
5.5 x 11.5 mm
Final Drill
6.5 x 11.5 mm
Final Drill
6.5 mm Depth
Gauge
6.5 mm
Tap
13 mm 2.0 Initial Drill Parallel Pin
3.5 x 13 mm
Final Drill
4.5 x 13 mm
Final Drill
5.5 x 13 mm
Final Drill
6.5 x 13 mm
Final Drill
6.5 mm Depth
Gauge
6.5 mm
Tap
Implant
Length
Ø5.5 Drilling Sequence
8.5 mm 2.0 Initial Drill Parallel Pin
3.5 x 8.5 mm
Final Drill
4.5 x 8.5 mm
Final Drill
5.5 x 8.5 mm
Final Drill
5.5 mm Depth
Gauge
5.5 mm
Tap
10 mm 2.0 Initial Drill Parallel Pin
3.5 x 10 mm
Final Drill
4.5 x 10 mm
Final Drill
5.5 x 10 mm
Final Drill
5.5 mm Depth
Gauge
5.5 mm
Tap
11.5 mm 2.0 Initial Drill Parallel Pin
3.5 x 11.5 mm
Final Drill
4.5 x 11.5 mm
Final Drill
5.5 x 11.5 mm
Final Drill
5.5 mm Depth
Gauge
5.5 mm
Tap
13 mm 2.0 Initial Drill Parallel Pin
3.5 x 13 mm
Final Drill
4.5 x 13 mm
Final Drill
5.5 x 13 mm
Final Drill
5.5 mm Depth
Gauge
5.5 mm
Tap
Tap Protocol:
D1 & D2 – Required
D3 – Clinicians Discretion
D4 – Not recommended
DRILL
SEQUENCE
DRILLING SEQUENCE
NOTE: When placing a Ø4.5 mm or larger implant, the 3.8 mm Final Drills may not be necessary. Use of Implant Depth Gauges is
optional until the Final Drill for the diameter of implant being placed.
©2017 Keystone Dental, Inc.
100001-EN01 Rev F 08/2017
Smarter Thinking. Simpler Design.
Keystone Dental, Inc.
Global Headquarters
154 Middlesex Turnpike
Burlington, MA 01803 USA
General Inquiries: 781-328-3600
Customer Relations: 866-902-9272 or 781-328-3490
Fax: 866-903-9272 or 781-328-3400
Email: [email protected]
EMERGO Europe B.V
Prinsessgracht 20
2514 AP The Hague
The Netherlands
Caution, consult accompanying documents
Trademark Acknowledgements
“Smarter Thinking. Simpler Design.” and TiLobe are trademarks and registered trademarks of Keystone Dental, Inc.
0086
Keystone Dental,Inc.
5 Holland, Building 209
Irvine, CA 92618 USA
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